|The fatigue testing according to DIN EN 14299:2004 7.2.8 consists of the determination of the stent under simulated physiological strain conditions for 10 years (400 mio. cycles). Dimension, structure, struts and contact surfaces of the stent have to be inspected and evaluated.
The Fatigue-Testing-System of Certiga utilizes a closed tubing system with a physiological saline solution tempered at 37 ± 1ºC (if required) to simulate in-vivo conditions. The essential pressure level is generated by a dynamic actuator system. The displacement of the stent under in-vitro conditions is given by a reference-measurement. The automatic control runs according to this reference data. Depending on the structure of the stent, the system allows frequencies up to 100 hertz. A high-precision laser scanner scans the displacement of the stent at full length. The system is able to test up to 24 self expandable or balloon expandable stents simultaneously.
The testing system allows an intermediate analysis of a single stent that is transferred into a database system in the form of pictures and reports. At the end of testing all information of the testing procedure are summarized in a detailed final report.
The specifications are renewed at the moment and will be shortly available again.
This testing system is currently not available for sale.